The latest notice, a Form 483, was issued to Sun after the FDA completed an inspection of the Halol plant on Dec. 1, the company said. Such a notice is issued when the FDA finds that conditions at a drug plant violate US rules.

"While the scope of the potential investment has not been determined, we will announce the details of any plans following the completion of direct discussions between our leadership and the relevant US officials," it said in a statement.

This could have an impact on plans of several American companies that are planning to establish manufacturing base in India to take advantage of the 'Make in India' policies unveiled by the Indian government.

In the past few weeks, CDSCO has inspected around 135 manufacturing plants and laboratories all over the country with help from state regulators. The regulator's main focus is to assess the risk and quality standards of manufacturing units.

The latest notice, a Form 483, was issued to Sun after the FDA completed an inspection of the Halol plant on Dec. 1, the company said. Such a notice is issued when the FDA finds that conditions at a drug plant violate US rules.

"While the scope of the potential investment has not been determined, we will announce the details of any plans following the completion of direct discussions between our leadership and the relevant US officials," it said in a statement.

This could have an impact on plans of several American companies that are planning to establish manufacturing base in India to take advantage of the 'Make in India' policies unveiled by the Indian government.

In the past few weeks, CDSCO has inspected around 135 manufacturing plants and laboratories all over the country with help from state regulators. The regulator's main focus is to assess the risk and quality standards of manufacturing units.